Kornimate/medical-research-clean huggingface dataset:
heart failure precision medicine study

Conditions: Heart Failure

Summary: the study aims to test the hypothesis that multi-omics studies can identify heart failure profiles at risk of adverse outcomes and evaluate a telemonitoring intervention in the optimization of guideline-directed medical therapy.

in the us, the estimated prevalence of heart failure (hf) is 6.2 million and increasing. the mortality approaches 50% within 5 years of diagnosis and hf is the main cause of hospitalization among patients over 65 years of age. information on molecular states may enhance understanding of causes and pathophysiological processes, improve risk prediction, identify new therapeutic targets, and improve subclassification for targeted therapy. time-dependent phenomapping has been used to identify clinical and genomic differences in a longitudinal fashion, which provides a mechanistic link underlying pathophysiology of the disease and associated outcomes. studies including high-throughput molecular approaches (multi-omics) along with time-dependent phenomapping would likely be even more powerful. the overarching hypothesis of the study is that the integration of multi-omics studies with clinical variables can be implemented to identify patients at risk of adverse outcomes. to test this hypothesis we propose: (1) longitudinal profiling based on clinical data; (2) longitudinal multi-omics profiling; and (3) randomized of a telemonitoring intervention (sensor profiling) and the effectiveness in the optimization of guideline-directed medical therapy. to achieve these aims we propose to: (1) recruit a cohort of 1000 participants; (2) perform cardiovascular clinical characterization from electronic medical records; (3) perform multi-omics studies and (4) randomization of a telemonitoring intervention in the optimization of guideline-directed medical therapy. proving these hypotheses would identify different meaningful clinical groups of patients within a cohort of patients with similar clinical conditions, health care providers would have a better understanding of the heterogeneity of the disease and the need for different preventive and therapeutic approaches in the context of precision medicine.

Eligibility criteria:
inclusion criteria: * diagnosis of heart failure * objective evidence of cardiac abnormality of structure or function (abnormal echo) or elevated levels of b-type natriuretic peptide (\>100 pg/ml) * hf stage b-d and class i-iv exclusion criteria: * patients unable to consent * inability to comply with the protocol and follow-up requirements * patients unable to use a smartphone * patients assessed irregularly (less than two visits in one year) * history of htx * use of mechanical circulatory support device (mcsd) * comorbidities that, according to the pi, have the potential to interfere with the interpretation of the results

Keywords: heart failure multi-omics phenomapping precision medicine telemonitoring
clinical trial to evaluate mdw for early detection of sepsis

Conditions: Sepsis

Summary: this study is intended to clinically verify monocyte distribution width (mdw) parameter of dxh 900 hematology analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in emergency department (ed). this study is also aimed to provide study supporting data for the product to be marketed in china.

to verify the clinical performance of mdw parameter in detection of sepsis through a multicenter, prospective study of adults undergoing complete blood count with differential ("cbc with differential") in the ed. to clarify the cutoff 20.0 established in the pivotal trial. the cutoff was established for the objective of achieving the highest sensitivity at the optimal specificity level. patients whose mdw value is higher than the cutoff will be identified as sepsis patients and those whose mdw value is equal to or lower than the cutoff are non-sepsis patients.

Eligibility criteria:
inclusion criteria: * adult subjects (18-89 years) presenting to ed. * cbc with differential performed upon presentation as part of standard of care. * subject scheduled for at least 12 hours follow-up during ed (or inpatient, if admitted to the hospital) visit * signed the informed consent form exclusion criteria: * subjects previously enrolled in this study (i.e., re-enrollment to this study is not allowed). * the subject is discharged from the hospital within 12 hours after ed visit
adaptive portable essential tremor monitor

Conditions: Essential Tremor

Summary: the purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to monitor essential tremor (et) to better prescribe therapy to minimize symptoms and expand care for et patients.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * clinical diagnosis of essential tremor * able to provide informed consent exclusion criteria: * significant medical or psychiatric illness * not capable of following the required clinical instructions * serious medical conditions that compromise safety

Keywords: essential tremor motion sensors tremor
knee osteoarthritis and rehabilitation

Conditions: Knee Osteoarthritis

Summary: osteoarthritis (oa) is a chronic degenerative disease of articular cartilage that causes hypertrophic changes in bone. oa is a non-inflammatory progressive musculoskeletal disease and is one of the most common degenerative diseases in the general population. oa is characterized by progressive cartilage destruction in load-bearing joints, subchondral sclerosis, osteophyte formation, and some biochemical and morphological changes in the synovial membrane and joint capsule. common symptoms of knee osteoarthritis are; knee pain that increases with activity, limitation of normal joint movement of the knee, edema, and knee pain that begins with prolonged sitting. the aim of this study is to evaluate the effects of laser treatment applied in addition to conventional physiotherapy on pain, function, muscle strength and balance in patients with knee osteoarthritis who received prp.

oa is a non-inflammatory progressive musculoskeletal disease; damage begins in the cartilage and causes changes in the joint structure over time. although intra-articular injection approaches have been frequently used in the treatment of oa recently, intra-articular injections known as platelet rich plasma (prp) have also started to be used frequently. today, the areas of use of laser therapy have increased. when the laser beam is applied, it is absorbed by the tissue or scattered back. laser has photochemical, thermal and ionizing effects on tissues. laser has an analgesic effect by increasing endorphin synthesis and reducing c nerve fiber activation. laser indirectly increases microcirculation by increasing temperature in the tissue. although there are various studies on treatment options for oa in the literature, no studies have been found to investigate the effectiveness of laser treatment applied in addition to conventional treatment after prp. in our study, we aimed to evaluate the effects of laser treatment applied in addition to conventional physiotherapy on pain, function, muscle strength and balance in patients with knee osteoarthritis who received prp.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * being diagnosed with knee oa by a specialist physician * having had prp injection applied by a specialist physician * having unilateral knee oa * being stage i-stage iii in the kellgren-lawrence oa classification * being between the ages of 18-65 exclusion criteria: * being stage iv in the kellgren-lawrence oa classification * bmi being more than 40 kg/m2 * patients who do not cooperate well * patients with neurological or neuromuscular disease

Keywords: osteoarthritis intra-articular injection prp (platelet-rich plasma) physiotherapy laser treatment
investigation of the effect of using "curtain"

Conditions: Ultrasound Therapy; Complications; Fine Needle Aspiration Biopsy; Thyroid Nodule (Diagnosis)

Summary: thyroid nodules are among the common health problems in adulthood. thyroid cancers account for approximately 1% of all malignancies in a year.the majority of cancers are diagnosed by thyroid fine needle aspiration biopsy. the most commonly diagnosed cancer type is papillary thyroid cancer and accounts for 85% of all thyroid cancers.thyroid ultrasonography is the most important imaging method used in the evaluation of the thyroid gland and its nodules. it enables the detection of nodules and their characteristics and plays a role in deciding which nodules should be evaluated with fine needle aspiration biopsy.non-pharmacological treatment methods are interventions that can be used to reduce the side effects of medical, surgical or pharmacological treatments. by using medical treatment and complementary therapy together, nurses can reduce patients' anxiety, support their sleep, create a healing environment and increase their health level. as a non-pharmacological strategy, distraction can be seen as a cost-effective approach to reduce anxiety in procedures that would cause negative anxiety and increase the opportunity for ease of operation. the curtain method also typically involves the use of visually interesting curtains or partitions that can be drawn around the patient's examination area. these curtains may have calming images or vibrant patterns that can help shift the patient's focus away from the frightening procedure being performed.

research type: it was designed as a randomized controlled experimental study. research population and sample: the research sample will consist of patients with suspected thyroid mass who applied to a city training and research hospital. the sample of the study is expected to consist of 100 volunteer patients with suspected thyroid mass who applied to the hospital.

Eligibility criteria:
inclusion criteria: * suspicion of a mass in the thyroid * no vision problems exclusion criteria: * mental health problems

Keywords: the curtain ultrasound therapy; complications ultrasound thyroid nodule
effect of hyperthyroidism and its treatment in graves' disease to early marker of atherosclerosis

Conditions: Hyperthyroidism; Graves Disease; Atherosclerosis of Artery; Pathophysiology

Summary: during july 2019 to august 2020, a single-blind clinical trial was done to 36 patients with graves' disease. at the beginning of the study, subjects were accommodated into 2 groups, 17 into ptu groups and 19 into methimazole groups. there were 24 subjects who finished the study, 13 from ptu group and 11 from methimazole group. blood serum was collected for homa-ir, ldl-r, nfĸb, sicam-1, svcam-1 and se-selectin examination. meanwhile stiffness and thickness of carotid artery was measured using pwv and cimt.

this study was a single blind, randomized clinical trial study, conducted in cipto mangunkusumo national referral hospital from january 2019 to august 2020. we included all adult patient aged 18-65 years with newly diagnosed graves' disease or no prior anti-thyroid drugs medication for more than 1 month, who agreed to participate in the study. the exclusion criteria was pregnancy, history of coronary heart disease, known malignancy, current use of immunosuppressive medication, sepsis, thyroid crisis, or having allergic reaction to anti-thyroid drugs and other severe side effect. ethical approval was obtained from the research ethics committee of the faculty of medicine, universitas indonesia with approval number ket-784/un.2.f1/etik/ppm.00.02/2019. study participant was observed every month for 3 months. anti-thyroid drugs (ptu or methimazole) were given according to true simple randomization with adjusted dosage according to patient clinical assessment at every visit by their own endocrinologist. at baseline visit, first and third month follow up, blood serum was collected to analyse homa-ir, ldl-r, nfĸb, sicam-1, svcam-1 and se-selectin, meanwhile pwv and cimt were measured using radiofrequency ultrasound examination of carotid arteries. categorical data was presented in frequency (%), while numerical data was presented using mean (sd) if normally distributed or median (iqr) if not normally distributed. correlation pearson test was performed for normal distributed data and spearman test for not normal distributed data. to analyze the changes in parameter from baseline, first and third month, repeated anova and general linear model test was performed. for not normally distributed data, transformation into normally distributed data was performed and the data was presented as geometric mean (ci 95%).

Eligibility criteria:
inclusion criteria: * adult patients aged 18-65 years * newly diagnosed graves' disease or no prior anti-thyroid drugs medication for more than 1 month * agreed to participate in the study exclusion criteria: * pregnancy * history of coronary heart disease * known malignancy * current use of immunosuppressive medication sepsis, thyroid crisis * having allergic reaction to anti-thyroid drugs and other severe side effect

Keywords: hyperthyroidism graves disease atherosclerosis pathophysiology insulin resistance lipid marker inflammatory marker pwv cimt
clinical trial of a new rectum cooling system on patients of hypoxic-ischemic brain damage

Conditions: Hypoxic-Ischemic Encephalopathy

Summary: this study will try to evaluate the effectiveness and safety of a new method for achieving mild hypothermia, i.e.,mild hypothermia therapy through rectum. half of participants will be treated by the widely-used hyper-hypothermia blanket method, while the other half will be treated by the investigators' new method.

mild hypothermia therapy has been proved to be beneficial to patients with severe traumatic brain injury. currently a variety of cooling methods can achieve mild hypothermia,the hyper-hypothermia blanket being the most widely-used one. hyper-hypothermia blanket is a waterbed mattress connected to a thermostat-controlled water tank. water is cooled in the tank and recycled between the tank and the mattress so that the patients sleeping on the mattress can be stably cooled. the operation is basically program-controlled ,but the whole system is quite expensive. the investigators came up with a new cooling system which is very simple and accessible. a condom inserted with two 10# gastric tube and one 6# gastric tube and ringed with a rubber band is inserted into the patient's rectum, and ice-cold saline is pumped in through one 10# gastric tube and drained out from the other 10# gastric tube, the 6# gastric tube connected to the pressure monitor. cooling rate is controlled by the flow speed of cold saline. the investigators will evaluate the effectiveness and safety of this new method for achieving mild hypothermia.

Eligibility criteria:
inclusion criteria: * neonatal hie * after cardiopulmonary resuscitation (cpr) * severe craniocerebral injury (gcs \< 8) * acute central nervous system infection and severe brain edema or lasting convulsion * severe cerebral edema caused by various metabolic factors exclusion criteria: * end-stage heart failure * uncorrected serious cardiovascular dysfunction * active intracranial hemorrhage not under control * platelet count \< 50 \* 10\^9 / l

Keywords: mild hypothermia hypoxic-ischemic encephalopathy
the diagnostic validity of the urea breath test

Conditions: Helicobacter Pylori Infection

Summary: 1. to compare the diagnostic accuracy of the 13c-urea breath test between using the citric acid as test meal and controlled group by endoscopic biopsy methods(histology, clotest and h. pylori culture). 2. to compare the delta value of 13co2 results between before and after ingestion of citric acid as test meal.

1-1 screening (visit 1, from -6 to -8 weeks) and h. pylori eradication 1. to accept the agreement, confirm inclusion/exclusion criteria, and evaluate the baseline characteristics of patients 2. h. pylori eradication * first eradication: ppi-based triple therapy (standard dose of ppi b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for 1 week), and sequential therapy (initial 5-day therapy with a combination of ppi b.i.d and amoxicillin 1g b.i.d, followed by 5 days of ppi b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d) * rescue therapy: bismuth-containing quadruple therapy \[ppi b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.\] for 1-2 weeks, or moxifloxacin-containing triple therapy (moxifloxacin 400 mg q.d., amoxicillin 1g b.i.d., and ppi b.i.d.) for 1-2 weeks. 1-2 baseline (visit 2, 0 week): urea breath test 1. reconfirm inclusion and exclusion criteria 2. randomization for ubt test (citric acid group vs control group) 3. in citric acid group: taking 4 g of citric acid solving in 200 ml of water 10 minutes before ubt. 4. perform ubt in both group 1-3) endoscopic surveillance (visit 3, 6 or later months) 1. endoscopic surveillance for final h. pylori status after ubt * histology, clotest or h. pylori culture 2. statical analysis for diagnostic accuracy of the ubt between citric acid group and controlled group: sensitivity, specificity, positive predictive value, negative predictive value, false positive rate, and false negative rate. 2. selecting 40 patients who showed ubt result between 2.5 to 4.0 in controlled group, the investigators are planning to reperform 13c-ubt after giving citric acid as test meal. and then, the investigators compare the change of ubt result before and after ingestion citric acid as test meal.

Eligibility criteria:
inclusion criteria: * male and female korean adult (aged over 18 years) * the patients who diagnosed h. pylori infection and received h. pylori eradication therapy exclusion criteria: * age under 18 years * patients who took any drug which could affect the study results such as proton pump inhibitor, h2 blocker, mucosal protective agents and antibiotics * advanced gastric cancer or other malignancy * abnormal liver function test or liver cirrhosis * abnormal renal function or chronic kidney disease * other severe concurrent disease

Keywords: helicobacter pylori infection eradication urea breath test
nab-paclitaxel plus carboplatin versus nab-paclitaxel plus capecitabine in the treatment of advanced triple-negative breast cancer

Conditions: Triple Negative Breast Cancer; Nab-paclitaxel

Summary: this is a multi-center , open-lable clinical trial. triple-negative breast cancer (tnbc) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (er) and the progesterone receptor (pr) and do not over express her2. tnbc is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. the purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced tnbc and up to one prior line of systemic treatment for metastatic disease. maintenance therapy with capecitabine after completion of combination chemotherapy.


Eligibility criteria:
inclusion criteria: 1. females with age between 18 to 70 years old; 2. histologically confirmed triple negative breast cancer; 3. no more than one-line prior treatment for locally advanced or metastatic breast cancer; 4. have at least one measurable lesion as per the recist criteria (version 1.1); 5. eastern cooperative oncology group (ecog) performance status less than or equal to one; 6. patients with life expectancy of at least 3 months; 7. bone marrow function：neutrophils (≥1.5×10\^9/l), platelets (≥100×10\^9/l), hemoglobin (≥90 g/l); 8. renal and hepatic function: serum creatinine≤ 1.5×institutional upper limit of normal (uln); ast and alt ≤ 2.5 × uln; total bilirubin≤1.5×uln, or patients with gilbert's syndrome ≤ 2.5 × uln; 9. patients had good compliance with the planned treatment, understood the research process and written informed consent. exclusion criteria: 1. patients with heart disease above grade ii (including grade ii) identified by new york heart association (nyha) scores; 2. brain metastasis; 3. recurrence or metastasis within 6 months after capecitabine withdrawal; 4. recurrence or metastasis within 6 months after platinum withdrawal; 5. progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months; 6. patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding; 7. patients who had grade 2 or above peripheral neuropathy; 8. patients with severe systemic infection or other serious diseases; 9. patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants; 10. patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer; 11. pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial; 12. participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given; 13. the researchers considered the patients who were not suitable for enrollment.

Keywords: nab-paclitaxel carboplatin capecitabine triple negative breast cancer maintenance therapy